FDA announcements and Insilico Medicine's official press releases

Insilico's AI-Designed ISM6331 Gets FDA Approval, Orphan Drug Status for Tumors

Aug 10, 2024, 01:00 AM

Insilico Medicine has achieved a significant milestone with its AI-designed TEAD inhibitor, ISM6331, receiving both FDA Investigational New Drug (IND) approval and Orphan Drug Designation. This innovative therapy targets solid tumors and mesothelioma, marking a notable advancement in the company's clinical pipeline. Since 2021, Insilico Medicine has nominated 18 preclinical drug candidates, with nine advancing to further stages. The approval of ISM6331 underscores the potential of AI in drug discovery and development.